EP2496193B1 - Scellement étanche pour un appareil de stomie - Google Patents

Scellement étanche pour un appareil de stomie Download PDF

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Publication number
EP2496193B1
EP2496193B1 EP10776289.0A EP10776289A EP2496193B1 EP 2496193 B1 EP2496193 B1 EP 2496193B1 EP 10776289 A EP10776289 A EP 10776289A EP 2496193 B1 EP2496193 B1 EP 2496193B1
Authority
EP
European Patent Office
Prior art keywords
sealing
base plate
stoma
urging part
sealing wafer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP10776289.0A
Other languages
German (de)
English (en)
Other versions
EP2496193A1 (fr
Inventor
Alastair Willoughby
Gary Stacey
Thomas Bates Jackson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coloplast AS
Original Assignee
Coloplast AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coloplast AS filed Critical Coloplast AS
Publication of EP2496193A1 publication Critical patent/EP2496193A1/fr
Application granted granted Critical
Publication of EP2496193B1 publication Critical patent/EP2496193B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404—Details or parts
    • A61F5/4408—Means for securing receptacles or bags to the body otherwise than by adhesives, e.g. belts, straps or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/448—Means for attaching bag to seal ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/449—Body securing means, e.g. belts, garments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable

Definitions

  • the invention relates to a seal for an ostomy appliance which seals around a stoma.
  • Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, an adhesive barrier member (or base plate) is attached to the wearer's abdomen/back/chest. In case of a one-piece appliance, a receiving member or bag is permanently attached to the base plate. In case of a two-piece appliance, the adhesive barrier member forms part of a body side member, and a receiving member or bag is attached releasably to the body side ostomy member for receiving exudates or output from the stoma. When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin, is normally removed and replaced by a fresh appliance.
  • the attachment means for attaching an ostomy receiving bag may for example be a system known per se comprising matching coupling rings or matching flanges and adhesive surfaces engaging with and sealing against a flange area of the body side member.
  • the service time of the body side ostomy member depends inter alia on the amount and the aggressiveness of the exudates and of the sealing between the stoma and the body side ostomy member.
  • the sealing depends on the fit to the stoma.
  • GB2041753 discloses a flexible stoma-receiving sealing duct integral with or fixed to a stomabag, the duct, in use, contacting and extending around and along the stoma.
  • the interior of the stomaduct may have spaced sealing lamellae, and the spaces between the lamellae may be filled up with soft material.
  • a sealing wafer according to the preamble of claim 1 is disclosed in GB-A-2 041 753 .
  • This provides a sealing wafer which is particularly suitable for use with a stoma around which the skin has an uneven curvature, such as a retracted stoma where the stoma has pulled back resulting in a crater-like area...
  • a resilient urging part facilitates adaption to any surface level difference and provides a planar attachment platform.
  • the urging part is formed of a sheet which is folded with alternating folds so as to achieve a corrugated shape so that the resilience is achieved through spring-like properties.
  • such a sealing wafer can be used for many different sizes and types of uneven skin surfaces around a stoma, and thus the need to provide many different sealing wafers in order to accommodate many different stomas is significantly reduced.
  • the urging part extends annularly around the through-going hole.
  • the through-going hole is preformed in order to facilitate application. This provides a seal against the skin surface around the stoma.
  • the attachment platform of the sealing wafer may extend in a sealing part through the through-going hole and back past where the urging part extends between the attachment platform and the sealing part.
  • a sealing rib can be provided on the proximal surface of the attachment platform and extend annularly around the urging part when looking at the proximal surface of the attachment platform.
  • the attachment platform is in the shape of a disc, having a relatively large surface area in relation to its thickness.
  • the disc can have many shapes, typically annular and circular, but may also have a squared, triangular or ellipsoidal shape.
  • a second urging part extends annularly around the first urging part. This allows the sealing further ability to adapt to the topography of the skin.
  • a base plate in another aspect, comprises a central through-going hole for receiving a stoma, wherein the sealing wafer is arranged in the central through-going hole.
  • an ostomy appliance which comprises a sealing wafer as described above and an ostomy collecting bag attachable to the distal surface of the attachment platform.
  • Such an ostomy collecting bag may be attached to the distal surface of the attachment platform by, for example, an adhesive coupling or a mechanical coupling.
  • the ostomy collecting bag may be permanently attached during manufacturing by, for example, a weld or glue.
  • Fig. 1 , 2 and 3 show one embodiment of the sealing wafer according to the invention in section.
  • FIG. 1 One embodiment of a sealing wafer 1 arranged in an ostomy base plate 2 is shown in figs. 1 , 2 and 3 .
  • the embodiment is shown in section along a symmetry line of both the sealing wafer and the base plate.
  • the base plate 2 is formed of an adhesive flange 3 whereon a coupling ring 4 is arranged.
  • the coupling ring is attached to the distal side of the adhesive flange 3.
  • the distal side/surface should be understood as being a part of an element facing away from the body when the ostomy device is placed around the stoma, while any reference to a proximal side/surface should be understood as being part of an element facing towards the body during use.
  • the coupling ring is formed to receive a corresponding coupling ring (not shown) arranged on an ostomy collecting bag (not shown).
  • the adhesive flange is formed of a backing layer whereon a skin friendly adhesive has been disposed on its proximal side.
  • a skin friendly adhesive has been disposed on its proximal side.
  • these elements have not been illustrated but are simply shown in general as the adhesive flange.
  • a first through-going hole 5 is formed in the centre of the base plate, defined by a first inner edge area 6 of the base plate.
  • the first through-going hole has a size which is large enough to accommodate the sealing wafer and a stoma.
  • the base plate is formed without the first through-going hole. In such cases, the user will cut out a hole in a size and shape especially suitable for the sealing wafer and the individual stoma.
  • the sealing wafer 1 is arranged in the first through-going hole 5.
  • the sealing wafer is formed of a thermoplastic elastomer (TPE).
  • TPE thermoplastic elastomer
  • Such an elastomer may be selected from the group consisting of SEBS, SBS, SIS and TPO (which is a mixture of PP, PE and non cross-linked EPDM rubber).
  • SEBS polyethylene glycol
  • SBS polystylene
  • SIS which is a mixture of PP, PE and non cross-linked EPDM rubber
  • the sealing wafer is very soft and flexible.
  • the sealing wafer will typically have a hardness of 20 Shore A - 50 Shore A, and the different elements will have a material thickness ranging from 0,1 mm - 2mm, typically between 0,3mm - 1 mm.
  • the sealing wafer 1 consists of an elastomeric sheet 13 having an outer periphery defined by an annular flat outer flange 11 and an inner periphery defined orifice surrounding part 16.
  • a flat outer flange 11 defines the periphery of the sealing wafer.
  • the flat outer flange enables the sealing wafer to be mounted on the inner edge area 6 which defines the first through-going hole 5 of the base plate using conventional methods, such as adhesive or welding.
  • the elastomeric sheet 13 extends from the inside of this outer flange 11, towards the centre of the ring.
  • the elastomeric sheet is not planar, rather it is frustoconical with the inner part of the sheet closer to the user than the plane of the outer flange when the seal is not deformed under load.
  • This re-entrant section is made up of two regions. A first region continues from the elastomeric sheet and curves towards the user to form an orifice surround 16. The second portion 15 continues from the end of the orifice surround 16 away from the axis of rotation of the device for a short distance. This portion 15 is the inner seal part.
  • Figure 3 illustrates how the base plate 2 and the sealing wafer 1 are applied for use.
  • the outer flange 11 is attached to the inner edge area 6 of the base plate. This may be done by the user right before application or may already be done during manufacturing.
  • the base plate 2 is then attached to skin 40 surrounding a stoma 41.
  • the orifice 17 of the sealing wafer which is defined by the orifice surround 16 is aligned with the stoma so that the inner seal 15 forms a user contacting portion of the seal which sits upon the stoma close to the orifice 42 of the stoma 41.
  • the orifice 42 of the stoma opens out through the orifice 17 of the sealing wafer 1.
  • An urging part 14 is formed integrally with the elastomeric sheet.
  • the urging part is made up of a convoluted elastomer part of the same material as the rest of the sealing wafer, located on the elastomeric sheet, so that when the inner seal 15 is deformed in the axial direction towards the elastomeric sheet 13 the urging part 14 will contact the inner seal 15 and provide a force that opposes this deformation.
  • the urging part 14 provides a resilient buffer between the elastomeric sheet 13 and the inner seal 15. This allows the inner seal to easily conform to the contour of the stoma.
  • the resilience of the urging part is dependent on a number of factors. In particular, by changing the softness of the material and the thicknesses of the urging part, the skilled person is able to achieve a suitable resilience. The choice of resilience will also affect the pressure by which the inner seal 15 pushes against the stoma. The person skilled in the art will understand that the resilience of the urging part should be chosen differently for different users, since the form and type of stomas may vary significantly and thus also the force on which the inner seal 15 is urged onto the stoma should also be varied. However, as a rule of thumb the skilled person would chose a resilience which results in the force exerted on the stoma by the inner seal being less than the diastolic blood pressure in order to reduce the risk of pressure wounds and necrosis.
  • the overall shape, both profile and thickness, and material of the elastomeric sheet 13, the orifice surround 16 and the inner seal 15 are chosen in such a way, for example as described above, that when a load is applied (steady state or transiently) by the stoma onto the sealing part, the device will maintain the convex profile of the inner surface.
  • the sealing wafer may be manufactured with orifice surrounds 16 having different diameters. For example, with a diameter of 10, 15 and 20mm.
  • a second outer sealing feature in the form of an elastomeric o-ring 12 that is integrally formed with the elastomeric sheet 13.
  • This outer seal feature is designed to prevent any stoma discharge that may breach the inner seal 15 from reaching the adhesive area of the base plate and causing the entire appliance to lose adhesion to the user.
  • the elastomeric sheet 13 must be harder and less prone to distortion than the resilient elements 12 and 14. If not, the sealing would flex instead of the resilient elements.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Claims (10)

  1. Plaquette d'étanchéité (1) conçue pour être disposée dans un trou de réception de stomie (5) d'une plaque de base (2) comprenant une plateforme de fixation s'étendant d'une périphérie extérieure (11) conçue pour être fixée à la plaque de base (2) vers une périphérie intérieure (16) définissant un trou traversant (17) destiné à recevoir une stomie (41), la plaquette d'étanchéité (1) comprenant en outre au moins une première partie de sollicitation (14) s'étendant transversalement à partir de la surface proximale orientée vers l'utilisateur lors de l'utilisation de la plateforme de fixation, la première partie de sollicitation (14) étant élastique dans la direction transversale à la surface proximale, caractérisée en ce que la première partie de sollicitation (14) est constituée d'une feuille pliée suivant des plis alternés.
  2. Plaquette d'étanchéité (1) selon la revendication 1, dans laquelle la première partie de sollicitation (14) s'étend de façon annulaire autour du trou traversant (17).
  3. Plaquette d'étanchéité (1) selon la revendication 2, dans laquelle la plateforme de fixation s'étend dans une partie d'étanchéité (15) à travers le trou traversant et dans le sens inverse au-delà de la première partie de sollicitation (14) de telle sorte que la première partie de sollicitation (14) s'étende entre la plateforme de fixation et la partie d'étanchéité (15).
  4. Plaquette d'étanchéité (1) selon l'une quelconque des revendications 1, 2 ou 3, dans laquelle une nervure d'étanchéité (12) est prévue sur la surface proximale de la plateforme de fixation et s'étend de façon annulaire autour de la première partie de sollicitation (14).
  5. Plaquette d'étanchéité (1) selon l'une quelconque des revendications 1 à 4, dans laquelle la plateforme de fixation présente la forme d'un disque.
  6. Plaquette d'étanchéité (1) selon l'une quelconque des revendications 1 à 5, dans laquelle une seconde partie de sollicitation s'étend de façon annulaire autour de la première partie de sollicitation (14).
  7. Plaque de base (2) comprenant une plaquette d'étanchéité (1) selon l'une quelconque des revendications 1 à 6, la plaque de base (2) comprenant un trou traversant central (5) destiné à recevoir une stomie (41), la plaquette d'étanchéité (1) étant disposée dans le trou traversant central (5).
  8. Appareil de stomie comprenant une plaque de base (2) selon la revendication 7, et une poche de collecte de stomie pouvant être fixée à la surface distale de la plaque de base (2).
  9. Appareil de stomie selon la revendication 8, dans lequel la poche de collecte de stomie est fixée à la surface distale de la plaque de base (2) au moyen d'un accouplement adhésif.
  10. Appareil de stomie selon la revendication 8, dans lequel la poche de collecte de stomie est fixée à la surface distale de la plaque de base (2) au moyen d'un accouplement mécanique (4).
EP10776289.0A 2009-11-02 2010-11-02 Scellement étanche pour un appareil de stomie Active EP2496193B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200970187 2009-11-02
PCT/DK2010/050293 WO2011050816A1 (fr) 2009-11-02 2010-11-02 Scellement étanche pour un appareil de stomie

Publications (2)

Publication Number Publication Date
EP2496193A1 EP2496193A1 (fr) 2012-09-12
EP2496193B1 true EP2496193B1 (fr) 2015-03-11

Family

ID=43432340

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10776289.0A Active EP2496193B1 (fr) 2009-11-02 2010-11-02 Scellement étanche pour un appareil de stomie

Country Status (6)

Country Link
US (1) US8764717B2 (fr)
EP (1) EP2496193B1 (fr)
CN (1) CN102655827B (fr)
BR (1) BR112012010285B1 (fr)
RU (1) RU2566078C2 (fr)
WO (1) WO2011050816A1 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8449513B2 (en) * 2010-12-27 2013-05-28 Benson Turtleneck Barrier, Llc Ostomy barrier seal
US8672908B2 (en) 2011-03-07 2014-03-18 Hollister Incorporated Convex barrier ring
EP2922508B1 (fr) 2012-11-20 2021-03-24 ConvaTec Technologies Inc. Sac de stomie en une pièce
HUE043066T2 (hu) 2012-12-06 2019-08-28 Coloplast As Illeszthetõ osztómiás alaplemez
CN105358103A (zh) * 2013-05-03 2016-02-24 佩里森斯有限公司 用于引导来自造口的输出物的装置
WO2015116651A1 (fr) 2014-01-28 2015-08-06 Hollister Incorporated Plaque frontale pour stomie ayant un collier pour stomie inversible
US11051969B2 (en) 2015-03-16 2021-07-06 Coloplast A/S Ostomy device
CA2997225A1 (fr) * 2015-09-11 2017-03-16 Coloplast A/S Dispositif de stomie
WO2017059869A1 (fr) * 2015-10-08 2017-04-13 Coloplast A/S Élément côté corps d'un appareil de stomie
US10881546B2 (en) * 2015-10-20 2021-01-05 Coloplast A/S Body side member of an ostomy appliance
GB2548892A (en) * 2016-03-31 2017-10-04 Univ Limerick An ostomy attachment for use in reducing the incidence of chemical dermatitis
JP6985290B2 (ja) * 2016-04-20 2021-12-22 ホリスター・インコーポレイテッドHollister Incorporated オストミーバリア
CA3037598C (fr) * 2016-10-03 2022-05-10 Hollister Incorporated Barriere de stomie a convexite reglable
WO2019164479A1 (fr) * 2018-02-21 2019-08-29 Alden M D Dmitri Procédé et dispositif pour la gestion de fluides corporels fuyant d'une incision de tube de drainage chirurgical
USD947373S1 (en) * 2019-12-06 2022-03-29 Hollister Incorporated Convex insert for ostomy appliance

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US7172581B2 (en) * 2001-09-24 2007-02-06 Coloplast A/S Ostomy appliance with a removable, washable and reusable sealing member
DK175862B1 (da) * 2001-09-24 2005-04-18 Coloplast As Stomiindretning
DK200300018A (da) * 2003-01-10 2004-07-11 Coloplast As stomiindretning
GB2409978B (en) 2004-01-19 2008-02-13 Peter Andrew Priest Fistula connector
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EP2303201B1 (fr) * 2008-06-19 2017-05-10 ConvaTec Technologies Inc. Accessoire de stomie pour diriger une sortie d'effluent
US8419021B2 (en) * 2008-10-31 2013-04-16 Ti Group Automotive Systems, L.L.C. Ring seal with insert

Also Published As

Publication number Publication date
BR112012010285A2 (pt) 2017-07-04
RU2566078C2 (ru) 2015-10-20
EP2496193A1 (fr) 2012-09-12
US8764717B2 (en) 2014-07-01
WO2011050816A1 (fr) 2011-05-05
CN102655827A (zh) 2012-09-05
BR112012010285B1 (pt) 2020-01-21
RU2012121881A (ru) 2013-12-10
US20120323192A1 (en) 2012-12-20
CN102655827B (zh) 2014-12-17

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